510(k) · Cleared
ClearedMedrad Phased Array 1.5T Shoulder Imaging Surgace Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Feb 11, 1997 as substantially equivalent to K960901 (Medrad, Inc., 1996) after a 70-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Feb 11, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K892235 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892235 | GE Shoulder Surface Coil, Cat. #M1085AN | General Electric Co. | 1989 | — |
| −1 | K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface Coil | Medrad, Inc. | 1996 | — |
| 0 (this device) | K964854 | Medrad Phased Array 1.5T Shoulder Imaging Surgace Coil | Medrad, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960901 | Medrad Phased Array 1.5T Shoulder Imaging Surface CoilSummary page 2…MRI Surface Coil PROPRIETARY NAME: Medrad Phased Array 1.5T Shoulder Imaging Surface Coil PREDICATE DEVICES: Medrad Phased Array 1.5T Shoulder Imaging Surface Coil - K960901 DEVICE DESCRIPTION: The Medrad Phased Array 1.5T Shoulder imaging Surface Coil is a rigid RF receive only magnetic field pickup… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K960901.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of shoulder region and the upper and lower extremeties with a specific size and shape to…
Read the full statement (187 words)
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of shoulder region and the upper and lower extremeties with a specific size and shape to facilitate placement on the anatomy area of interest. This placement resuits in a higher Signal To Noise Ratio(SNR) in the region near the surface coil. The greater SNR permits more effective imaging through the use of a smaller FOV and thinner slices.
The intended ROI for imaging includes the anterior and posterior musculoskeletal area of the shoulder and the upper and lower extremeties.
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended to aid physician diagnosis in the shoulder, upper, and lower extremety regions.
Patient fitness and suitability for MR! must be determined by the individual physician trained in the field of Diagnostic Magnetic Resonance Imaging.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964854: Medrad Phased Array 1.5T Shoulder Imaging Surgace Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964854
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026